NCT07635082

Brief Summary

Extended letrozole protocol versus letrozole plus Inositol for Induction of ovulation in letrozole resistant PCOS Women

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

May 18, 2026

Last Update Submit

June 4, 2026

Conditions

Polycystic Ovary Syndrome (PCOS) WomenPolycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Ovulation Rate

    The proportion of participants achieving ovulation after treatment with either an extended letrozole protocol (5 mg daily for 7 days) or letrozole plus inositol protocol in letrozole-resistant PCOS women.

    At the end of Cycle 1 (each treatment cycle is 28 days).

Secondary Outcomes (2)

  • Spontaneous Ovulation Rate

    Up to 3 months after treatment initiation.

  • Clinical Pregnancy Rate

    Up to 12 weeks after treatment initiation.

Study Arms (2)

Extended Letrozole Protocol (7 days

PLACEBO COMPARATOR
Drug: ELP (Extended Letrozole Protocol)

Letrozole + Inositol Protocol

EXPERIMENTAL
Drug: LIP (Letrozole + Inositol Protocol)

Interventions

ELP (Extended Letrozole Protocol)DRUG

? ELP (Extended Letrozole Protocol) Participants allocated to this arm will receive letrozole 5 mg orally once daily, starting on day 2 of the menstrual cycle and continued for 7 consecutive days. Follicular development will be monitored using transvaginal ultrasonography every 48 hours starting after the last dose of letrozole until confirmation of ovulation. When at least one dominant follicle reaches a mean diameter of 18-20 mm, human chorionic gonadotropin (hCG) will be administered to trigger ovulation. Timed intercourse will be advised accordingly. Endometrial thickness will be measured on the day of ovulation trigger. This protocol may be repeated for up to 3 consecutive cycles in case ovulation is not achieved.

Extended Letrozole Protocol (7 days
LIP (Letrozole + Inositol Protocol)DRUG

? LIP (Letrozole + Inositol Protocol) Participants allocated to this arm will receive myo-inositol 2 g orally twice daily for a duration of 3 months prior to ovulation induction. In the subsequent cycle, letrozole 5 mg orally once daily will be administered starting on day 2 of the menstrual cycle for 5 consecutive days. Follicular monitoring will be performed using transvaginal ultrasonography every 48 hours after the last dose of letrozole until ovulation is confirmed. Ovulation will be triggered using hCG injection when at least one follicle reaches 18-20 mm in diameter, followed by timed intercourse. Compliance with inositol intake and any adverse effects will be documented throughout the study period.

Letrozole + Inositol Protocol

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria.
  • Letrozole-resistant PCOS patients who failed to ovulate after receiving letrozole 5 mg daily for 5 days for three consecutive cycles.
  • Age 18 to 35 years.
  • Body mass index (BMI) ≤ 30 kg/m².
  • Normal uterine cavity and patent fallopian tubes confirmed by hysterosalpingography (HSG) and/or laparoscopy.
  • Partner with normal semen analysis.
  • Willing and able to provide informed consent.

You may not qualify if:

  • Thyroid dysfunction.
  • Hyperprolactinemia.
  • Diabetes mellitus.
  • Congenital adrenal hyperplasia.
  • Adrenal causes of hyperandrogenism.
  • Use of insulin-sensitizing medications (e.g., metformin) during the study period.
  • Chronic liver disease.
  • Chronic kidney disease.
  • Contraindications to pregnancy.
  • Contraindications or hypersensitivity to inositol or letrozole.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University Hospital

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511, Egypt

Location

Related Links

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

SMG1 protein, humanLetrozole

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Teaching assistant

Study Record Dates

First Submitted

May 18, 2026

First Posted

June 9, 2026

Study Start

February 1, 2024

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Locations

EG(1)